Stent/graft device and method for open surgical placement

ABSTRACT

A method and a stent/graft device for intraoperative repair of a damaged portion of a body vessel. The stent/graft device has a length at least as long as the length of the damaged portion of the vessel undergoing repair, and is positioned within the vessel such that the device at least spans the length of the damaged vessel portion. The stent/graft device is securely engaged with the vessel at the site of the damage in a manner such that migration of the device in said vessel is inhibited.

RELATED APPLICATION

The present patent document claims the benefit of the filing date under35 U.S.C. § 119(e) of Provisional U.S. Patent Application Ser. No.60/702,924, filed Jul. 27, 2005, which is hereby incorporated byreference.

BACKGROUND

1. Technical Field

The present invention relates generally to the field of stents and stentgrafts, and more particularly, to a stent/graft device and method foropen surgical, or “intraoperative”, placement in a body vessel of apatient.

2. Background Information

Emergency physicians frequently encounter patients having traumaticinjury to a body vessel. Significant damage to a body vessel, such as ablood vessel, may expose a patient to deleterious conditions such as theloss of a limb, loss of function of a limb, increased risk of stroke,impairment of neurological functions, and compartment syndrome, amongothers. Particularly severe cases of vascular injury and blood loss mayresult in death. Examples of treatments that are commonly performed byemergency physicians to treat vessel injury secondary to trauma includeclamping the vessel with a hemostat, use of a balloon tamponade,ligation of the damaged vessel at or near the site of injury, or theinsertion of one or more temporary shunts.

In the case of traumatic injury to blood vessels, the use of temporaryshunts has been linked to the formation of clots. Shunts are generallyplaced as a temporary measure to restore blood flow, and to stopexcessive blood loss. This may require returning the patient to theoperating room for treatment and removal of the clots, often withinabout 36 to 48 hours of the original repair. When the patient hasstabilized (generally a few days later), the shunt is typically removedand replaced with a vascular graft, such as a fabric graft that is sewninto place. Ligation of the damaged vessel may result in musclenecrosis, loss of muscle function, edema, or compartment syndrome withpotential limb loss or death.

Due to the nature of the vascular injury that may be encountered, theuse of shunts, repairing and/or ligating of a vessel often requires thatsuch treatments be performed at great speed, and with a high degree ofphysician skill. Such treatments may occupy an undue amount of the timeand attention of an emergency physician at a time when other pressingissues regarding the patient's treatment may also require immediateattention. In addition, since the level of particularized skill requiredmay exceed that possessed by the typical emergency physician,particularly traumatic episodes may require the skills of a speciallytrained physician. Such physicians are specially trained to address theparticular trauma, such as a vascular trauma, and to stabilize thepatient in the best manner possible under the circumstances of the case.

It would be desirable to provide a system and method for dealing withvascular trauma (arterial and venous) in a manner that is timeeffective, that addresses the trauma at hand to the extent possible, andthat utilizes techniques that may be readily practiced by an emergencyphysician.

BRIEF SUMMARY

The present invention addresses the problems of the prior art byproviding a stent/graft device and method for intraoperative placementin a body vessel.

In one form thereof, the invention comprises a method for intraoperativerepair of a damaged portion of a body vessel. A stent/graft device has alength at least as long as a length of the damaged vessel portionundergoing intraoperative repair. The stent/graft device is positionedwithin the vessel in a manner such that the device spans at least thelength of the damaged portion of the vessel. The stent/graft device isengaged with the vessel at the vessel damaged portion in a manner suchthat migration of the stent/graft device in said vessel is inhibited.

In another form thereof, the invention comprises a stent/graft devicefor intraoperative repair of a damaged portion of a body vessel. Thedevice comprises an elongated generally cylindrical stent body and agraft material covering at least a portion of the stent body. The deviceis expandable from a compressed condition having a diameter less than adiameter of the vessel to an expanded condition having a diameter atleast as large as the diameter of the vessel. The device is positionablewithin the vessel in the compressed condition and engageable with thevessel in the expanded condition.

In yet another form thereof, the invention comprises a stent/graftdevice for intraoperative repair of a damaged portion of a body vessel.The device comprises a generally cylindrical body having a passagewaytherethrough. A connector is positioned at least one axial end of thebody. An axial end of the connector extends into the passageway andanother axial end of the connector extends from said body. The axial endextending into the passageway has a diameter such that the end is snuglyreceived in the body. The axial end extending from the body includes amechanism for effecting engagement with the vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a stent/graft device for intraoperativeplacement according to one embodiment of the present invention;

FIG. 2 is a sectional view of the main body of the stent/graft devicealong lines 2-2 of FIG. 1;

FIG. 3 is a side view of a connector of the stent/graft device of FIG.1;

FIG. 4 is a side view of fragment of a damaged body vessel that haspreviously been subjected to a traumatic episode;

FIG. 5 is a side view of the damaged vessel of FIG. 4 with thestent/graft device of FIG. 1 positioned at the site of the vesseltrauma;

FIG. 6 is a side view of an alternative embodiment of an expandablestent/graft device suitable for intraoperative placement according tothe present invention, with the stent/graft device shown in a compressedcondition;

FIG. 7 shows the stent/graft device of FIG. 6 in an expanded condition;

FIG. 8 illustrates the stent/graft device of FIG. 6 as positioned in adamaged vessel, with the stent/graft device in the compressed condition;

FIG. 9 shows the stent/graft device of FIG. 8 in the damaged vessel inthe expanded condition;

FIG. 10 is a side view of an alternative embodiment of a stent/graftdevice positioned in a compressed condition in a damaged vessel;

FIG. 11 is a side view of another alternative embodiment of anexpandable stent/graft device according to the present invention, withthe stent/graft shown in a compressed condition; and

FIG. 12 shows the stent/graft device of FIG. 11 in an expandedcondition.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings, and specific language will be used to describe the same.It should nevertheless be understood that no limitation of the scope ofthe invention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

FIG. 1 illustrates one embodiment of an inventive stent/graft device 10for open surgical, or intraoperative, placement. In this embodiment,stent/graft device 10 comprises a generally cylindrical body 12, havinga connector 14 disposed at either or both axial ends of cylindrical body12. Stent/graft device 10 has a size and shape suitable for placementwithin a body vessel, such as a blood vessel (either an artery or vein),and most particularly, for placement at the site of a vascular trauma.

For convenience, the inventive device is referred to herein as a“stent/graft” device. The device has features in combination with aconventional stent, as well as with a conventional stent graft. In someembodiments of the present invention, one or more conventionalexpandable stents comprise a part of the actual stent/graft device, andin particular, function as retention members to seal the ends of atubular graft material to the vessel. In one form, the inventive devicecomprises a stent graft that is used for intraoperative repair of injuryand other trauma to a body vessel, such as a blood vessel.

Typically, stent/graft body 12 comprises a hollow, elongated, generallyflexible material, such as a flexible polymeric material, having a lumen13 extending therethrough. Stent/graft body 12 can be formed fromconventional materials well-known in the medical arts, such as silicone,polyurethane, polyamide (nylon), as well as other flexible biocompatiblematerials. In addition, body 12 can be formed from known fabric graftmaterials such as woven polyester (e.g. DACRON®) and expandedpolytetrafluoroethylene (ePTFE; e.g. GORE-TEX®), or from abioremodelable material. A bioremodelable material can provide anextracellular matrix that permits, and may even promote, cellularinvasion and ingrowth into the material upon implantation. Non-limitingexamples of suitable bioremodelable materials include reconstituted ornaturally-derived collagenous materials. Suitable collagenous materialsmay include an extracellular matrix material (ECM) that possessesbiotropic properties, such as submucosa, renal capsule membrane, dermalcollagen, dura mater, pericardium, fascia lata, serosa, peritoneum orbasement membrane layers. Suitable submucosa materials may include, forexample, intestinal submucosa, including small intestinal submucosa,stomach submucosa, urinary bladder submucosa, and uterine submucosa.

Connector 14 may comprise any shape suitable for use in fixedly engagingstent/graft device 10 within a body vessel. In the non-limiting exampleshown in FIG. 3, connector 14 comprises an elongated tubular structurehaving a main body portion 15, a recessed portion 16 adjacent each axialend of main body portion 15, and a generally frusto-conical end portion17 at each axial end of the connector. Preferably, connector 14 is sizedsuch that one end of the connector is snugly received within the lumenof stent/graft body 12 up to about the axial midpoint of main connectorbody portion 15, as shown in FIG. 1. For best results, the outerdiameter of main body portion 15 should be at least as large as theinner diameter of flexible cylindrical body 12 to insure a tight andsecure fit of connector 14 within the lumen of cylindrical body 12.

Generally, connector 14 will comprise a relatively rigid structure, suchas a metal, metal alloy, or a high-strength polymer, having a lumentherethrough. Connector 14 has sufficient strength to maintain itsstructural integrity upon tying of one or more sutures around thecircumference of the connector, in a manner to be described. Generally,any biocompatible composition having the requisite strength may beutilized, as long as the composition has sufficient strength so as tonot be unduly compressed upon application of pressure on its outersurface caused by the sutures.

Preferably, one or more sutures 18 are tied around the circumference ofstent/graft body 12 to firmly secure connector 14 within stent/graftbody lumen 13. For best results, respective sutures 18 are tied at orabout the recessed portion 16 of connector 14 that has previously beendisposed within lumen 13. In this manner, as the suture is tied aboutflexible stent/graft body 12, a portion of body 12 is compressed withinthe recessed portion 16.

Although FIG. 3 illustrates one preferred shape of a connector 14 foruse in stent/graft device 10, the connector need not necessarily havethe shape shown therein. As one non-limiting alternative, connector 14may be provided with a simple cylindrical configuration throughout itslength. It is most preferable that the connector 14 has a diameter suchthat it may be snugly received within the axial end portion ofstent/graft body 12, and that it is receivable within the lumen of thebody vessel undergoing repair. However, as stated, it is believed thatrecesses 16 are beneficial in providing a recess, or groove, withinwhich sutures 18, 20 can be received as they are tightened around theouter surface of the respective stent/graft body 12 (suture 18), orvessel 30 (suture 20) (FIG. 5), thereby establishing a more secureconnection. The optional frusto-conical axial ends 17 of connector 14facilitate the insertion of the device into the vessel, and improve theability of stent/graft device 10 to remain anchored within the vessel.

One example of the intraoperative use of stent/graft device 10 intreating a vascular trauma will now be described. FIG. 4 illustrates ablood vessel 30 that has previously been subjected to a traumaticepisode. In this case, it will be observed that a portion 32 of bloodvessel 30 has been torn away or otherwise severely damaged. Asillustrated in FIG. 5, after the body has been opened, stent/graftdevice 10 is manually placed within vessel 30 by the physician, in amanner such that stent/graft body 12 spans at least the length ofdamaged vessel portion 32.

In the embodiment shown, stent/graft device 10 is anchored to inhibitmigration within vessel 30 by tying one or more sutures 20 around thevessel at an exposed portion of connector 14. For best results, sutures20 are tied around connector 14 at exposed recess portion 16. In thismanner, sutures 20 compress a portion of vessel 30, such that the vesselis pressed within the recess 16 at each axial end to ensure a tight andsecure connection, as shown in FIG. 5. Open surgical placement of theinventive stent/graft device in the manner described can generally beaccomplished in a minimal amount of time, often on the order of about 2minutes. To the contrary, conventional repair techniques may take aslong as 45 minutes, or even longer in some instances.

A stent/graft device for use in open surgical, or intraoperative,placement according to the present invention need not necessarily beconfigured as shown in FIG. 1. Other configurations are also suitablefor such placement and are considered within the scope of the invention.One alternative embodiment of a stent/graft device 40 suitable for suchplacement is shown in FIG. 6. In this embodiment, stent/graft device 40is selectively expandable from a collapsed, or “non-expanded”, conditionas shown in FIG. 6, to an expanded condition, as shown in FIG. 7.

Stent/graft device 40 comprises an elongated, generally cylindricalstent body 44. Body 44 may be formed, e.g., of one or more wires in aconventional stent crossing pattern of wires. A fabric graft 45 isprovided to cover stent body 44 in well-known fashion. The wires formingstent body 44 may be any conventional wires commonly utilized for suchpurposes, such as metals and metal alloys. Non-limiting examples ofsuitable compositions include stainless steel and shape memorymaterials, such as nitinol, as well as compositions that are visibleunder common medical imaging techniques such as magnetic resonanceimaging (MRI). One non-limiting example of a preferred composition thatis visible under imaging techniques is titanium. Fabric graft 45 maycomprise any graft material well-known in the medical arts, including,but not limited to, the materials described above with reference tostent/graft device 10. The graft material must be capable of expansionas shown in the figures. EPTFE is a particularly preferred graftmaterial. Those skilled in the art will appreciate that other knowntypes of stents and graft materials may be substituted for those shownand described herein.

In FIG. 6, non-expanded stent/graft device 40 is shown positioned withina conventional delivery sheath 42. Sheath 42 is a tubular structurehaving a conventional mechanism for facilitating the removal of thestent/graft device from the sheath following proper placement within thevessel, such as a pull-tab mechanism or a pusher. In the embodiment ofFIG. 6, the removal mechanism comprises a pull-tab type mechanism,namely string 41. When string 41 is pulled in the direction of thearrow, sheath 42 is split in a longitudinal direction, and maythereafter be peeled away from the stent graft. One example of asuitable splittable mechanism is the pull-tab mechanism used inconnection with PEEL-AWAY® sheaths, available from Cook Incorporated, ofBloomington, Ind. Alternatively, other conventional mechanisms forremoving a device from a delivery sheath, and/or for splitting a sheathfor removal, may be utilized. Sheaths of the type shown and describedherein are well known in the art, and those skilled in the art willappreciate that many known sheaths may be substituted for the sheathshown and described herein, each of which is considered within the scopeof the invention.

As stated, stent/graft device 40 is expandable from a compressedcondition to an expanded condition. Thus, following delivery of thestent/graft by splitting the sheath or other appropriate deliverymechanism, stent/graft device 40 expands from the contracted conditionshown in FIG. 6 to the expanded condition shown in FIG. 7. Preferably,stent/graft device 40 is provided with anchoring structure, such asbarbs 43, provided along at least a portion of the outer circumferenceof the device to anchor the expanded stent/graft device in the vessel.Those skilled in the art will appreciate that many appropriate anchoringstructures are known in the art, such as hooks, “fish-scales”, and thelike, any of which may be utilized in place of, or in addition to, thebarbs shown in FIGS. 6 and 7. Although the embodiment of FIGS. 6 and 7includes barbs along the entire length of the stent/graft, this is notrequired, and barbs can alternatively be positioned at one or morediscrete locations along the length of the stent/graft device.Similarly, although the barbs shown in the figures each have a sharp tippointing in the same direction, this is exemplary only, and barb tipscan be provided that face in the same, or opposite, directions. Thoseskilled in the art can readily select an appropriate arrangement of barbtips for a particular use.

FIGS. 8 and 9 illustrate the intraoperative placement of stent/graftdevice 40 at the site of a vascular trauma, such as the traumaillustrated in FIG. 4. As shown in FIG. 8, sheath 42, having stent/graftdevice 40 loaded therein in a collapsed state, is intraoperativelyplaced within vessel 30 at the site of vascular trauma 32. Sheath 42 issplit by pulling string 41 in the direction of the arrow, and the sidesof sheath 42 may be peeled or otherwise removed in conventional fashionfrom the stent/graft device. Once stent/graft device 40 is freed fromthe constraints of sheath 42, it thereafter expands in the vessel, asshown in FIG. 9. Preferably, stent/graft device 40 has an expanded outerdiameter at least as large, and preferably somewhat larger, than theinner diameter of vessel 30.

FIG. 10 illustrates a modification of the arrangement shown in FIGS.6-9. In this case, delivery sheath 52 is provided with two pull strings,rather than the single string shown in FIG. 6. In this variation, eachof the strings 51 is positioned at a separate axial end of the sheath52. The strings are then pulled in the direction of the respectivearrows to split the sheath. The sheath is then pulled away, freeing thestent/graft device 40 for expansion within the vessel 30.

Another embodiment of the present invention is illustrated in FIGS. 11and 12. In this embodiment, stent/graft device 60 comprises anarrangement of multiple axially-aligned stents 64, rather than thesingle wire stent body 44 as illustrated in FIGS. 6 and 7. In theembodiment shown, there are two stents 64 disposed at opposite ends ofexpandable stent/graft device 60. A sheath 62 having one or more pullstrings 61 is provided as before. Stent graft body 65 can be formed ofany of the compositions previously described, and if desired, mayinclude a plurality of barbs 63 or similar anchoring structures.

Although the arrangement shown in FIGS. 11 and 12 includes two stents 64disposed at axial ends of device 60, numerous alternative arrangementsare within the scope of the invention. As one possible alternative, thedevice can include a series of stents disposed along all, or a part of,the length of the stent/graft device. Such stents can be connected toeach other, be placed immediately adjacent to each other, or spaced adiscrete distance from each other. The fabric of the stent/graft deviceneed not necessarily cover, or span, all stented portions of the device,although sufficient fabric should be provided to at least span the siteof the vascular damage. Thus, with this embodiment, a stent/graft devicecan be provided having a plurality of stents disposed along the lengthof the device. If desired, the stent/graft device can be sized such thatit has a greater length and/or a greater number of stents than wouldtypically be required for use. The physician can then trim thestent/graft device to a desired length. In this manner, the medicalfacility need not maintain a large number of stent/graft devices ofdifferent lengths, but rather, can stock one or more elongated devicesthat can be trimmed by the physician to the desired length immediatelyprior to use.

With an embodiment including multiple expandable stents, such as theembodiment illustrated in FIGS. 11 and 12, the splittable outer sheathneed not necessarily extend the entire length of the device. Rather, aseparate splittable sheath may be provided to cover each of the stentedportions of the stent/graft, and the unstented portions may remainuncovered. In this manner, each of the sheaths can be split with, e.g. astring or a conventional mechanism, to effect controlled expansion ofthe stents, and concomitantly, of the graft material, within the damagedvessel.

According to the present invention, a stent/graft device can have alength of virtually any size for use in treating a vascular trauma.Preferably, a stent/graft device will have a length between about 1 and10 cm, more preferably, between about 3 and 8 cm, and still morepreferably, about 6 or 7 cm. It is preferred that the stent/graft willbe slightly longer than the length of the damaged vascular portionundergoing repair. For convenience, the stent/graft can be structuredsuch that at least a portion of either, or both, axial ends of the stentgraft can be trimmed by the physician to a desired length.

The stent/graft device described herein can also include a coating ofone or more therapeutic agents. Therapeutic agents for use asbio-compatible coatings are well known in the art. Non-limiting examplesof suitable bio-active agents that may be applied to the stent/graftdevice include thrombo-resistant agents, antibiotic agents, anti-tumoragents, antiviral agents, anti-angiogenic agents, angiogenic agents,anti-mitotic agents, anti-inflammatory agents, angiostatin agents,endostatin agents, cell cycle regulating agents, genetic agents,including hormones such as estrogen, their homologs, derivatives,fragments, pharmaceutical salts and combinations thereof. Those skilledin the art will appreciate that other bio-active agents may be appliedfor a particular use. The bio-active agent can be incorporated into, orotherwise applied to, portions of the stent/graft device by any suitablemethod that permits adequate retention of the agent material and theeffectiveness thereof for its intended purpose.

Although the device has been described in connection with its primaryintended use for repair of vascular trauma, those skilled in the artwill appreciate that the device may also be used to repair othertraumatic conditions. Non-limiting examples of such conditions includeaneurysms, such as abdominal aorta aneurysms.

It is therefore intended that the foregoing detailed description beregarded as illustrative rather than limiting, and that it be understoodthat it is the following claims, including all equivalents, that areintended to define the spirit and scope of this invention.

1. A method for intraoperative repair of a damaged portion of a bodyvessel, comprising: providing a stent/graft device, said stent/graftdevice having a length at least as long as a length of said damagedvessel portion undergoing said intraoperative repair; positioning saidstent/graft device within said vessel such that said device at leastspans said damaged vessel portion length; and engaging said stent/graftdevice with said vessel at said vessel damaged portion in a manner suchthat migration of said stent/graft device in said vessel is inhibited.2. The method of claim 1, wherein said stent/graft device includes aconnector at at least one axial end thereof, and stent/graft device isfixedly engaged with said vessel at said connector.
 3. The method ofclaim 2, wherein said connector is fixedly engaged with said vessel byone or more sutures.
 4. The method of claim 3, wherein said connectorcomprises at least one recessed portion, said connector fixedly engagedwith said vessel at said recessed portion.
 5. The method of claim 1,wherein said stent/graft device includes a connector at each axial endthereof, and each of said connectors includes at least one recessedportion, each said connector fixedly engaged with said vessel at saidrecessed portion via one or more sutures.
 6. The method of claim 1,wherein said stent/graft device comprises an elongated generallycylindrical stent and a graft material covering at least a portion ofsaid stent, said device being expandable from a compressed conditionhaving a diameter less than a diameter of the vessel to an expandedcondition having a diameter at least as large as the diameter of thevessel, said device positioned within said vessel in said compressedcondition and engaged with said vessel in said expanded condition. 7.The method of claim 6, wherein said stent/graft device includes ananchoring mechanism for anchoring said device to said vessel.
 8. Themethod of claim 6, further comprising a sheath for said stent/graftdevice, said sheath substantially enclosing said device when said deviceis positioned within said vessel in said compressed condition.
 9. Themethod of claim 8, wherein said sheath includes a mechanism forselectively splitting said sheath for effecting expansion of saiddevice.
 10. The method of claim 1, wherein said stent/graft devicecomprises a plurality of axially spaced stents, and a graft materialspanning axially adjacent stents and covering at least a portion of saidstents, said stents being expandable from a compressed condition havinga diameter less than a diameter of the vessel to an expanded conditionhaving a diameter at least as large as the diameter of the vessel, saiddevice positioned within said vessel when said stents are in saidcompressed condition and engaged with said vessel when said stentsexpand to said expanded condition.
 11. The method of claim 10, whereinsaid stent/graft device includes an anchoring mechanism for anchoringsaid device to said vessel.
 12. The method of claim 10, wherein a sheathis provided for said stent/graft device, said sheath substantiallyenclosing said device when said stents are in said compressed condition.13. The method of claim 12, wherein said sheath includes a mechanism forselectively splitting said sheath for effecting expansion of saidstents.
 14. The method of claim 10, wherein said plurality of axiallyspaced stents comprises a pair of stents, said stents spaced such thatone of said stents is positioned at each axial end of said stent/graftdevice.
 15. The method of claim 14, wherein a respective sheath isprovided for each of said stents, each sheath enclosing a separate oneof said stents when said stent is in a compressed condition, each saidsheath being selectively removable for effecting expansion of saidstent.
 16. A stent/graft device for intraoperative repair of a damagedportion of a body vessel, comprising: an elongated generally cylindricalstent body and a graft material covering at least a portion of saidstent body, said device being expandable from a compressed conditionhaving a diameter less than a diameter of the vessel to an expandedcondition having a diameter at least as large as the diameter of thevessel, said device positionable within said vessel in said compressedcondition and engageable with said vessel in said expanded condition.17. The device of claim 16, wherein said stent body has a length atleast as long as a length of said damaged vessel portion undergoing saidintraoperative repair.
 18. The device of claim 16, wherein said stentbody comprises a plurality of axially spaced stents, and said graftmaterial covers said stents, said stents being expandable from acompressed condition having a diameter less than a diameter of thevessel to an expanded condition having a diameter at least as large asthe diameter of the vessel.
 19. The device of claim 16, wherein saidstent/graft device includes an anchoring mechanism for anchoring saiddevice to said vessel.
 20. A stent/graft device for intraoperativerepair of a damaged portion of a body vessel, comprising: a generallycylindrical body having a passageway therethrough; and a connectorpositioned at least one axial end of said body, an axial end of saidconnector extending into said passageway and another axial end of saidconnector extending from said body, said axial end extending into saidpassageway having a diameter such that said end is snugly received insaid body, said axial end extending from said body including a mechanismfor effecting engagement with said vessel.
 21. The device of claim 20,wherein said device comprises a connector positioned at each axial endthereof, each of said connectors including a portion adapted for fixedengagement with said vessel via one or more sutures.